Introduction The majority of the drugs in the late stage of the pipeline are being developed to target Gram-positive infections, including methicillin-resistant Staphylococcus aureus (MRSA). Progress has been slow, with many drugs held up by the US FDA's changing guidance on the design of antibiotic clinical trials. If successful, agents will be entering a large, but increasingly crowded, anti-MRSA market. Features and benefits Extensive analysis of clinical trial data and assessment of clinical and commercial attractiveness for pipeline antibacterials Discussion of future strategic opportunities to achieve success in an increasingly crowded antibacterials market Analysis of the ability of pipeline drugs to satisfy key unmet needs in the antibacterials space
Highlights Two promising antibacterials were launched in the US in 2011. Teflaro is the first cephalosporin to target MRSA, but enters an increasingly crowded market. Dificid is only the second drug in the US to be approved for Clostridium difficile-associated diarrhea, demonstrating reduced rates of relapse, however high pricing may prevent rapid uptake. Several antibiotics are in late stage development that target MRSA, from oral once daily drugs, to antibiotics that require only one or two doses per treatment course. Their convenience and potential to save significant hospital resources makes them very attractive therapies, but each will compete to reach the market first. Two highly anticipated combination therapies targeting serious Gram-negative infections, including multidrug-resistant pathogens, entered Phase III in 2011. If approved, they will be direct competitors as both cover many of the same organisms, but one has the ability to meet specific key unmet needs better than the other. Your key questions answered Identify key drugs within the antibacterials pipeline, success factors for recently launched brands, and the potential for new entrant products. Assess strengths, weaknesses, opportunities and threats of key pipeline antibacterials and how they influence clinical and commercial attractiveness. Understand the impact of events such as changing FDA guidances on clinical trial design, and successful and unsuccessful partnership deals.
Contains 111 pages and 56 tables/figures.
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